New Regulations for Pharmacy Compounding on the Horizon?

Compounded medicines, which are drugs mixed to meet an individual patient’s needs, play an essential role in the treatment of patients. In the past, compounding was typically done within the hospital pharmacy.

Today, however, nearly all hospitals, doctor’s offices, and home-health companies, get at least some of these types of drugs from pharmacy compounding facilities.

In response to the fungal meningitis outbreak caused by contaminated steroid injections, the oversight of pharmacy compounding practices and regulations governing them has come into question. In fact, a recent Boston Globe articlehighlights one legislator’s calls for tougher regulation of compounding pharmacies and his plan to introduce legislation that will strengthen the oversight of compounding pharmacies.

This is not the first time that the regulations over pharmacy compounding have been discussed; however at this point, no official legislation is in place. While it is difficult to predict if this new legislation will be successful, and if so, how it will affect current compounding practices across the country, this tragedy has certainly brought new scrutiny to the situation.

Pharmacy Compounding: Current Practices and Oversight

The American Society of Health-System Pharmacists (ASHP) has, in turn, published a risk based approach aimed at helping its members achieve compliance with the policies, procedures and controls promulgated under USP <797>.

Over the years, it has been unclear just how this would be enforced, under which authorities, and to what extent, especially for those entities not classified as drug manufacturers. One could surmise that the impetus for the USP <797> regulations was to create a framework for self-regulation, essentially best practices to be adopted by pharmacies and referenced by regulatory bodies that were involved in oversight of “traditional” pharmacy settings (Joint Commission on Accreditation of Healthcare Organizations, state boards of pharmacy, etc.).

A recent survey attempts to study the impact that USP <797> has had on the industry; in fact, 77% of those polled indicated that they had successfully implemented measures designed to achieve compliance with USP <797>. The survey cites financial constraints/budgetary limitations and physical plant challenges as the most significant barriers to compliance.

Today pharmacy compounding is regulated mostly by state pharmacy boards and/or departments of public health. While the FDA has some authority to inspect them, they are not necessarily subjected to the same type of oversight the FDA has over drug manufacturers. One reason for this is that compounded drugs are typically made for just one person, and regulation of that one product would not be feasible or practical for a patient requiring medication quickly.

Another survey was performed to assess whether or not states have implemented laws and regulation for sterile compounding. Based on the results provided there are a number of states with no laws or regulations referencing USP <797> or Sterile Compounding; the remaining appear to be split between those states that have (a) harmonized their laws with USP <797> and those that have (b) implemented their own laws and regulation for sterile compounding that do not cite USP <797>.

Impacts to Hospital Pharmacy Compounding

There are many reasons why a hospital outsources its compounding, including staffing issues, budget issues, quality assurance, and compliance. But the recent recall of compounded drugs from outsourced compounding operations may have an impact on this practice going forward. Some hospitals have plans to stop offering purchased compounds as soon as possible. One may deduce that this will, however, significantly increase the compounding workload within hospital pharmacies which will have an impact on the personnel, space, equipment and facility requirements necessary to achieve compliance with applicable sterile compounding laws and regulations.

It seems unlikely that all hospitals will be able to absorb the increase in workload that bringing compounding entirely in-house will mean, especially if increased regulations are imposed. There is no doubt that this will be a large part of the debate as the legislation makes its way through the US House and Senate.

Importance of Sterility in Pharmacy Compounding

How pharmacy compounding facilities are defined and how they differ from drug manufacturers will undoubtedly be a large part of the debate surrounding the proposed legislation and who will be ultimately responsible for enforcement.

One thing is for certain. The recent meningitis outbreak has reminded us of the importance of sterility and adherence to existing procedures and requirements when compounding pharmaceuticals.

USP <797> describes the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded. The Baker Company has also created an online library of links to articles and studies relevant to current trends and standards in pharmacy compounding.